UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018362
Receipt number R000021259
Scientific Title Usability of salt restriction education according to feedback of estimated urinary salt excretion from first morning urine samples.
Date of disclosure of the study information 2015/07/24
Last modified on 2016/12/22 10:04:28

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Basic information

Public title

Usability of salt restriction education according to feedback of estimated urinary salt excretion from first morning urine samples.

Acronym

Salt restriction education according to feedback of urinary salt excretion

Scientific Title

Usability of salt restriction education according to feedback of estimated urinary salt excretion from first morning urine samples.

Scientific Title:Acronym

Salt restriction education according to feedback of urinary salt excretion

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective was to evaluate the usability of salt restriction education of estimated urinary salt excretion from first morning urine samples.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

estimated urinary salt excretion

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Subjects is asked lifestyle modification based on their estimated urinary salt excretion

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

healthy volunteer

Key exclusion criteria

The exclusion criteria included subjects with physical, psychological, and social difficulties; those without the ability for self-selection and/or self-determination; those undergoing medical treatment with diuretics; or those with edema.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichiro Yasutake

Organization

Nakamura Gakuen University

Division name

Faculty of Nutritional Sciences

Zip code


Address

5-7-1 Befu Jonan-ku, Fukuoka, Japan

TEL

+81-92-851-2531

Email

yasutake@nakamura-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenichiro Yasutake

Organization

Nakamura Gakuen University

Division name

Faculty of Nutritional Sciences

Zip code


Address

5-7-1 Befu Jonan-ku, Fukuoka, Japan

TEL

+81-92-851-2531

Homepage URL


Email

yasutake@nakamura-u.ac.jp


Sponsor or person

Institute

Nakamura Gakuen University

Institute

Department

Personal name



Funding Source

Organization

Nakamura Gakuen University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2016 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 21 Day

Last modified on

2016 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021259


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name